Mansfield, MA, April 28, 2020 —
MANSFIELD, MA., Eurofins -Transplant Genomics, Inc. (“TGI”), announces that Dr. Peter Meintjes has joined the company as Chief Commercial Officer to lead the commercialization of TruGraf, the only blood test approved by CMS for surveillance to rule out “silent” subclinical acute rejection in kidney transplant recipients with stable graft function.
Dr. Meintjes joins TGI after six years at Omixon, world leader in pre-transplant HLA Typing, where he departs as CEO, having grown the company at a CAGR of >75% since its first full year of operation as a molecular diagnostics company. Dr. Meintjes was attracted to TGI by the unique opportunity of commercializing TruGraf®, a non-invasive blood test, with established reimbursement that can confirm the absence of “silent” subclinical acute rejection in kidney transplant recipients with stable renal function. TruGraf is significantly differentiated when compared with existing donor derived cell-free DNA (ddcfDNA) and creatinine/eGFR post-transplant kidney monitoring tests, which are only capable of confirming active rejection in already injured kidneys, without stable graft function.
Dr. Meintjes joins Founder and CEO Dr. Stan Rose, who has led TGI through receiving a Local Coverage Determination (LCD) for TruGraf in November 2019. TruGraf also benefits from the prospective CTOT-08 study, which demonstrated the prevalent incidence of silent subclinical rejection and the importance of early detection and treatment to longer term outcomes. The clinical utility and validity of TruGraf were established by using paired non-invasive liquid biopsies (blood samples) and invasive tissue biopsies (current gold standard for ruling out silent rejection) which demonstrated a 94% concordance. This highlights how TruGraf is the only test that can be used for routine surveillance to address two critical unmet clinical needs for kidney transplant recipients:
- ~35% of patients with stable graft function over two years are actually “silently” rejecting, and go untreated by waiting for evidence of clinical acute rejection (i.e. elevated creatinine or ddcfDNA), indicating damage already done, and leading to worse outcomes for patients
- ~75% of patients undergoing invasive surveillance biopsies were not experiencing any form of rejection, putting patients at unnecessary risks from those invasive procedures
By using TruGraf, nephrologists are empowered to make better treatment decisions for their patients. At the same time, patients who test negative are comforted by learning that they have adequate immune suppression (i.e. immune quiescence, graft stability, healthy kidneys) without having to be subjected to risky, costly and painful biopsies.
With the resources of parent company Eurofins, TGI is positioning for strong growth into the post-transplant kidney testing market after excellent adoption among early customers. TGI is hiring additional sales, medical science liaisons and marketing personnel to support the commercial expansion.
Eurofins U.S. Clinical Diagnostics
860 817 0151 or xiomaraortiz@EurofinsUS.com
About Eurofins – Transplant Genomics
Eurofins – Transplant Genomics (“TGI”) is a molecular diagnostics company committed to improving organ transplant outcomes, with an initial focus on kidney transplant recipients. Working with the transplant community, TGI is commercializing a suite of tests enabling diagnosis and prediction of transplant recipient immune status. Test results will support clinicians with information to optimize immune-suppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA laboratory in Fremont, CA.
Eurofins – a global leader in bio-analysis
Eurofins Scientific through its subsidiaries (hereinafter sometimes “Eurofins” or “the Group”) believes it is a scientific leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing. With about 45,000 staff in more than 800 laboratories across 47 countries, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group objective is to provide its customers with high-quality services, accurate results on time and expert advice by its highly qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and the most comprehensive range of testing methods.
As one of the most innovative and quality oriented international players in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world.
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